Methods and devices for accessing and retracting a capsule of a joint

ABSTRACT

Devices and methods are disclosed herein for accessing the hip joint. A first device can be securely attached to the capsule of a joint. The first device can tent the capsule to increase the volume of the peripheral compartment. A second device can be biased against the first device to pierce the tented capsule and create a portal. Devices and methods are also disclosed herein for distending the capsule of a joint. A distention device may access a portal established within the capsule. The distention device can expand the capsule by applying an expansive force within the peripheral compartment. The distention device can maintain distention of the peripheral compartment while other devices access the joint.

REFERENCE TO PENDING PRIOR PATENT APPLICATIONS

This patent application is a continuation of pending prior U.S. patentapplication Ser. No. 15/620,901, filed Jun. 13, 2017 by Pivot Medical,Inc. for METHODS AND DEVICES FOR ACCESSING AND RETRACTING A CAPSULE OF AJOINT (Attorney's Docket No. FIAN-69 CON 2), which patent application isa continuation of prior U.S. patent application Ser. No. 14/143,951,filed Dec. 30, 2013 by Pivot Medical, Inc. for METHODS AND DEVICES FORACCESSING AND RETRACTING A CAPSULE OF A JOINT (Attorney's Docket No.FIAN-69 CON), which in turn is a continuation of prior U.S. patentapplication Ser. No. 12/961,213, filed Dec. 6, 2010 by Thomas Weisel etal. for METHODS AND DEVICES FOR ACCESSING AND RETRACTING A CAPSULE OF AJOINT (Attorney's Docket No. FIAN-69), which patent application claimsbenefit of prior U.S. Provisional Patent Application Ser. No.61/266,785, filed Dec. 4, 2009 by Hanson S. Gifford et al. for METHODSAND DEVICES TO ACCESS A CAPSULE OF A JOINT (Attorney's Docket No.FIAN-020979-005000 PROV).

The four (4) above-identified patent applications are herebyincorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to medical devices and methods foraccessing a joint, and more specifically to devices and methods forproviding minimally invasive access into the hip joint.

BACKGROUND OF THE INVENTION

Obtaining arthroscopic access into orthopedic joints to perform surgicalprocedures can be extremely challenging. This is particularly true ofthe hip joint, which has two tissue barriers that must be crossed inorder to gain access to the inner part of the joint. The outer barrieris known as the capsule, a series of tight overlapping ligamentssurrounding the joint, effectively sealing off the hip joint from theremainder of the body. The area within the capsule is known as theperipheral compartment.

Within the peripheral compartment, the joint is fluidly sealed by askirt-like tissue known as the labrum which is attached to theacetabular rim and hugs tightly around the base of the femoral head. Thelabrum/femoral head interface creates a vacuum seal within the jointwhich helps to hold the femoral head tightly within the acetabulum. Inorder to gain access to the central compartment (i.e., the portion ofthe joint within the labrum lying between the femoral head andacetabulum) the seal of the labrum must be broken and instruments thenintroduced into the very narrow opening between the bottom edge of thelabrum and femoral head.

In arthroscopic surgery, access to the peripheral compartment istypically obtained through the use of elongate tubular devices (e.g.,arthroscopic portals or cannulas), which are inserted through thepatient's skin and through the ligaments of the capsule to provide atunnel or lumen through which instruments may be introduced. Multipleaccess portals are typically employed, with one access portal being usedfor visualization (e.g., for placement of an arthroscope), and theremaining portal(s) being available for the introduction of otherinstruments.

However, the creation of access portals can be problematic. For onething, the patient's anatomy (e.g., bone, blood vessels, nerves, etc.)can greatly restrict the possible portal locations. Furthermore, somehip structures (e.g., the articular cartilage on the femoral head, thearticular cartilage on the acetabular cup, etc.) can be quite delicate,thereby requiring great precision when forming the access portal so asto avoid damaging delicate structures. Additionally, some of theintervening tissue (e.g., the joint capsule) can be quite tough, thusrequiring substantial force to penetrate the tissue, and thereby raisingthe danger of accidental plunging as an access tool breaks through theintervening tissue. Such accidental plunging increases the risk ofinadvertently damaging delicate joint structures (e.g. articularcartilage).

Due to the numerous difficulties and concerns associated with forming anaccess portal, surgeons have traditionally resorted to a multi-stepprocedure for forming the access portal.

More particularly, surgeons have traditionally first passed a smallneedle (sometimes referred to as an access needle) down to the interiorof the hip joint. This is generally done by first using externalanatomical landmark and tactile feedback for needle guidance; then, asthe sharp tip of access needle enters the capsule of the joint andapproaches delicate structures (e.g. articular cartilage), fluoroscopyis used to carefully direct final needle placement. Inexperiencedsurgeons, or experienced surgeons dealing with particularly problematiccases, may also use fluoroscopy during the earlier stages of needleplacement.

Next, a guidewire is placed through the lumen of the access needle, thenthe access needle is removed. Next, the tissue surrounding the guidewireis opened laterally by passing a series of tissue dilators over theguidewire. These dilators progressively increase in diameter so as todilate the tissue disposed between the skin and the interior of thejoint.

Once the opening from the top surface of the skin down to the interiorof the joint has been established, a tubular liner (sometimes referredto as an “access cannula”) is inserted over the guidewire, and theguidewire may be withdrawn from the joint. This access cannula holds theincision open and provides a surgical pathway (or “corridor”) from thetop surface of the skin down to the interior of the hip joint, therebyenabling instrumentation (e.g., arthroscopes, surgical instruments,etc.) to be passed through the central lumen of the access cannula so asto reach the remote surgical site within the joint.

This multi-step process requires substantial effort on the part of thesurgeon, increases the instrumentation necessary for the procedure, andextends the duration of the procedure.

Surgeons have also created portals by inserting long spinal needles intothe joint under fluoroscopic guidance. In order to avoid damaging thecartilage of the hip joint with the needle, the femur is distracted fromthe pelvis by approximately 5 to 10 millimeters to create a gap betweenthe femoral head and the acetabulum of the pelvis. The needle isaccordingly guided into the gap.

Hip distraction typically requires the use a distraction table, asurgical table that includes a post placed against the patient'sperineum and a tensioning device which fastens to the patient's foot orankle and allows high forces (e.g., 50 to 70 pounds) to be exerted onthe patient's leg to distract the femur and create space within thejoint. These tables not only are large, cumbersome and expensive, butthey limit the mobility of the joint during the procedure and frequentlyproduce complications such as nerve damage.

Even with use of a distraction table, damage to the cartilage and otherjoint tissue may be difficult to avoid. The capsule surrounding the hipjoint is significantly denser and “tougher” than tissue externallysurrounding the capsule. Accordingly, a high amount of force is requiredto pierce the capsule, even with use of a sharp needle. However, thecapsule is relatively thin, 2 to 15 millimeters, and the high amount offorce required to pierce it can inadvertently cause a needle touncontrollably “pop” through the capsule and damage tissue beyond. Thespace within the peripheral compartment is also relatively small for usewith arthroscopic devices. Accordingly, several portals must be createdto enable proper access to the joint. Each time a portal is created, therisk of unintended harm is increased.

Methods and devices have been proposed for accessing the hip jointwithout using a distraction table. For example, commonly assigned U.S.patent application Ser. No. 12/483,446, filed Jun. 12, 2009, entitled“Methods and Apparatus for Joint Distraction”, the entirety of which isincorporated by reference herein, discloses various internal distractiondevices for distracting the hip and other joints. These devices useballoons or other expandable features placed within the centralcompartment to displace the femoral head further away from theacetabulum in order to allow access for surgical instruments. While suchdevices eliminate the need for a distraction table, challenges may stillbe encountered in introducing these devices into the peripheral andcentral compartments. Further, even where a conventional distractiontable is used, the placement of portals and the introduction ofinstruments into the peripheral and central compartments remainchallenging.

On account of the foregoing, there is a substantial need for a simpler,faster and more convenient approach for creating an access portal to theinterior of the hip joint.

More particularly, there is a substantial need for a new approach fordeploying an access cannula into the interior of the hip joint.

There is also a substantial need for locking an access cannula so thatits distal tip is constrained within the capsule of the hip joint so asto facilitate the insertion and removal of instruments.

In addition to the foregoing, there is also a significant need forcreating additional workspace once access is gained to the interior ofthe hip joint, whereby to afford surgeons improved visualization at thesurgical site and more room to maneuver.

SUMMARY OF THE INVENTION

These and other objects of the present invention are addressed by theprovision and use of a novel method and apparatus for accessing acapsule of a joint.

More particularly, in one embodiment of the present invention, a capsuleof a joint may be accessed by attaching a first device to the capsule ofthe joint. The capsule may then be distended by placing a second deviceinto the capsule through a passage in the first device.

In another embodiment of the invention there is provided a system forcreating a portal in a capsule of a joint. The system may include anelongated needle. The system may also include an elongated sheath withan inner surface. The inner surface may be diametrically sized to freelyslide over the elongated needle, the elongated sheath including aplurality of grasping members coupled near a distal end thereof.

Yet another embodiment of the invention provides a method for accessinga capsule of a joint. A needle may be advanced to a capsule of a joint.A sheath may be advanced over the needle to the capsule, the sheathholding an expansion device. Grasping members of the expansion devicemay be engaged into the capsule to secure the expansion device to thecapsule. The needle may be advanced through the capsule of the joint tocreate a penetration therein.

Yet another embodiment of the invention provides a system for creating aportal in a capsule of a joint. The system may include an elongatedneedle. The system may also include an elongated sheath with an innersurface. The inner surface diametrically may be sized to freely slideover the elongated needle. The system may also include an elongatedexpansion device, which may include a plurality of grasping members atone end of the expansion device, the expansion device may be radiallyconstrained by the inner surface of the elongated sheath.

Yet another embodiment of the invention provides a system for creating aportal in a capsule of a joint. The system may include an elongatedneedle. The system may also include an elongated sheath with an innersurface. The inner surface may be diametrically sized to freely slideover the elongated needle. The system may also include an elongatedexpansion device housed at the inner surface of the elongated sheath.The expansion device may have a plurality of grasping members at oneend, the grasping members being biased radially inward. An inner shaftmay be slidably disposed within the expansion device and sized to urgethe grasping members towards radially inward when distally advanced.

Yet another embodiment of the invention provides a method for accessinga capsule of a joint. A needle may be advanced to a capsule of a joint.A sheath may be advanced over the needle to the capsule, a wall of thesheath holding grasping members constrained in a straightenedconfiguration. The grasping members may be engaged into the capsule tosecure the sheath to the capsule.

The needle may be advanced through the capsule of the joint to create apenetration therein.

Yet another embodiment of the invention provides a system for creating aportal in a capsule of a joint. The system may include an elongatedsheath with an inner diameter sized to freely slide over the elongatedneedle. The elongated sheath may include a wall with a plurality ofpathways and including expandable zones between the pathways. Aplurality of wires may be slidably housed within the plurality ofpathways. The plurality of wires may include a plurality of hooks.

Yet another embodiment of the invention provides a method for accessinga capsule of a joint. A needle may be advanced to a capsule of a joint.A cannula may be advanced over the needle to the capsule. A firstportion of the cannula may be maintained in place. A second portion ofthe cannula may be rotated with respect to the stationary first portionto engage grasping members of the expansion device into the capsule tosecure the cannula to the capsule. The needle may be advanced throughthe capsule of the joint to create a penetration therein.

Yet another embodiment of the invention provides a system for accessinga capsule of a joint. The system may include an elongated inner tubeincluding a plurality of expandable hooks. An elongated outer tube maybe rotatably engaged to the inner tube. The outer tube may include aplurality of slots. The plurality of expandable hooks may be slidablyengaged with the plurality of slots.

Yet another embodiment of the invention provides a method for accessinga capsule of a joint. A capsule of a joint may be accessed. A cannulamay be attached to the capsule of the joint. A penetration may becreated in the capsule.

The capsule may be distended using a distension device.

Yet another embodiment of the invention provides a system for creating aportal in a capsule of a joint. The system may include an elongatedneedle. An elongated cannula may be diametrically sized to freely slideover the elongated needle. The cannula may have a plurality of graspingmembers at one end of the expansion device. An elongated distensiondevice may be moveably coupled to the elongated cannula.

Yet another embodiment of the invention provides a method for distendinga capsule of a joint. A capsule of a joint may be accessed. Apenetration through the capsule may be created. A delivery deviceholding a distention device maybe inserted into the penetration. Thedistention device may be deposited into the portal and removed from thedelivery device. The distention device may be activated to expand withinthe capsule.

Yet another embodiment of the invention provides a system for distendinga capsule of a joint. The system may include a piston device. The pistondevice may include first and second atraumatic bumpers. One atraumaticbumper may be attached to an end of the elongate body and the other toan end of the moveable shaft. The system may include an elongatedapplicator including a holding device removably coupled to one of thebumpers.

Yet another embodiment of the invention provides a method for distendinga capsule of a joint. A capsule of a joint may be accessed. A firstportal and a second portal may be created through the capsule. Amagnetic end of a first flexible strap may be guided into first portal.A magnetic end of a second flexible strap may be guided into the secondportal. The magnetic ends may couple within the capsule. Either thefirst or second strap may be withdrawn from the capsule to place amid-portion of the other of the first or second strap within thecapsule. The non-withdrawn first or second strap may be pulled from bothportals to distend the capsule away from the joint.

Yet, another embodiment of the invention provides a system fordistending a capsule of a joint. The system may include a first andsecond cannula. The system may also include a first and second elongatedstrap. Each strap may be sized to slide within the first and secondcannula. Each strap may include a magnetic member attached at an end ofeach strap configured to magnetically attract the magnetic member on theother strap.

In one preferred form of the invention, there is provided a method foraccessing a capsule of a joint, the method comprising:

accessing a capsule of a joint;

attaching a first device to the capsule of the joint;

distending the capsule; and

placing a second device into the capsule through a passage in the firstdevice.

In another preferred form of the invention, there is provided a systemfor creating a portal in a capsule of a joint, the system comprising:

an elongated needle; and

an elongated sheath with an inner surface, the inner surfacediametrically sized to freely slide over the elongated needle, theelongated sheath including a plurality of grasping members coupled neara distal end thereof.

In another preferred form of the invention, there is provided a methodfor accessing a capsule of a joint, the method comprising:

advancing a needle to a capsule of a joint;

advancing a sheath over the needle to the capsule, the sheath holding anexpansion device;

engaging grasping members of the expansion device into the capsule tosecure the expansion device to the capsule; and

advancing the needle through the capsule of the joint to create apenetration therein.

In another preferred form of the invention, there is provided a systemfor creating a portal in a capsule of a joint, the system comprising:

an elongated needle;

an elongated sheath with an inner surface, the inner surfacediametrically sized to freely slide over the elongated needle; and

an elongated expansion device including a plurality of grasping membersat one end of the expansion device, the expansion device being radiallyconstrained by the inner surface of the elongated sheath.

In another preferred form of the invention, there is provided a systemfor creating a portal in a capsule of a joint, the system comprising:

an elongated needle;

an elongated sheath with an inner surface, the inner surfacediametrically sized to freely slide over the elongated needle;

an elongated expansion device housed at the inner surface of theelongated sheath, the expansion device including a plurality of graspingmembers at one end, the grasping members being biased radially inward;and an inner shaft slidably disposed within the expansion device andsized to urge the grasping members radially outward when distallyadvanced.

In another preferred form of the invention, there is provided a methodfor accessing a capsule of a joint, the method comprising:

advancing a needle to a capsule of a joint;

advancing a sheath over the needle to the capsule, a wall of the sheathholding grasping members constrained in a straight configuration;

engaging the grasping members into the capsule to secure the sheath tothe capsule; and

advancing the needle through the capsule of the joint to create apenetration therein.

In another preferred form of the invention, there is provided a systemfor creating a portal in a capsule of a joint, the system comprising:

an elongated sheath with an inner diameter sized to freely slide overthe elongated needle, the elongated sheath including a wall with aplurality of pathways and including expandable zones between thepathways; and

a plurality of wires slidably housed within the plurality of pathways,the plurality of wires including a plurality of hooks.

In another preferred form of the invention, there is provided a methodfor accessing a capsule of a joint, the method comprising:

advancing a needle to a capsule of a joint;

advancing a cannula over the needle to the capsule;

maintaining a first portion of the cannula in place;

rotating a second portion of the cannula with respect to the stationaryfirst portion to engage grasping members of the expansion device intothe capsule so as to secure the cannula to the capsule; and

advancing the needle through the capsule of the joint to create apenetration therein.

In another preferred form of the invention, there is provided a systemfor accessing a capsule of a joint, the system comprising:

an elongated inner tube including a plurality of expandable hooks; and

an elongated outer tube rotatably engaged to the inner tube, the outertube including a plurality of slots, the plurality of expandable hooksbeing slidably engaged with the plurality of slots.

In another preferred form of the invention, there is provided a methodfor accessing a capsule of a joint, the method comprising:

accessing a capsule of a joint;

attaching a cannula to the capsule of the joint;

creating a penetration in the capsule; and

distending the capsule using a distension device.

In another preferred form of the invention, there is provided a systemfor creating a portal in a capsule of a joint, the system comprising:

an elongated needle;

an elongated cannula diametrically sized to freely slide over theelongated needle, the cannula including a plurality of grasping membersat one end of the expansion device; and an elongated distension devicemoveably coupled to the elongated cannula.

In another preferred form of the invention, there is provided a methodfor distending a capsule of a joint, the method comprising:

accessing a capsule of a joint;

creating a penetration through the capsule;

inserting a delivery device holding a distention device into thepenetration;

depositing the distention device into the portal and removing thedelivery device; and

activating the distention device to expand within the capsule.

In another preferred form of the invention, there is provided a systemfor distending a capsule of a joint, the system comprising:

a piston device comprising:

-   -   an elongate body, a moveable shaft extending from the elongate        body;    -   first and second atraumatic bumpers, one atraumatic bumper being        attached to an end of the elongate body and the other to an end        of the moveable shaft; and    -   an elongated applicator, the elongated applicator including a        holding device removably coupled to one of the bumpers.

In another preferred form of the invention, there is provided a methodfor distending a capsule of a joint, the method comprising:

accessing a capsule of a joint;

creating a first portal and a second portal through the capsule;

guiding a magnetic end of a first flexible strap into the first portal;

guiding a magnetic end of a second flexible strap into the secondportal, the magnetic ends coupling within the capsule;

withdrawing either the first or second strap from the capsule to place amid-portion of the other of the first or second strap within thecapsule; and

pulling on the non-withdrawn first or second strap from both portals todistend the capsule away from the joint.

In another preferred form of the invention, there is provided a systemfor distending a capsule of a joint, the system comprising:

first and second cannulas; and

first and second elongated straps, each strap sized to slide within thefirst and second cannula, each strap including a magnetic memberattached to an end of the strap configured to magnetically attract themagnetic member on the other strap.

In another preferred form of the invention, there is provided anapparatus for accessing the interior of a joint and creating additionalwork space within the interior of a joint, the apparatus comprising:

an elongated shaft having a distal end and a proximal end, and a lumenextending between the distal end and the proximal end; and

an elongated sleeve for disposition over the elongated shaft, theelongated sleeve having a distal end and a proximal end and a lumenextending between the distal end and the proximal end, wherein thedistal end of the elongated shaft comprises an expandable collar.

In another preferred form of the invention, there is provided a methodof accessing the interior of a joint and creating additional work spacewithin the interior of a joint, the method comprising:

providing an apparatus comprising:

-   -   an elongated shaft having a distal end and a proximal end, and a        lumen extending between the distal end and the proximal end; and    -   an elongated sleeve for disposition over the elongated shaft,        the elongated sleeve having a distal end and a proximal end and        a lumen extending between the distal end and the proximal end,        wherein the distal end of the elongated shaft comprises an        expandable collar;

passing the apparatus into the joint so that the distal end of theelongated sleeve is positioned on the interior of a capsule of a joint;

expanding the expandable collar; and

tenting the capsule so as to create additional work space within thecapsule of the joint.

In another preferred form of the invention, there is provided anapparatus for retracting a capsule of a joint, the apparatus comprising:

a length of suture; and

an anchor attached to one end of the length of suture.

In another preferred form of the invention, there is provided a methodof retracting a capsule of a joint, the method comprising:

providing a length of suture and an anchor attached to one end of thelength of suture, wherein the anchor comprises a body which isconfigured to assume (i) a first, folded configuration when the body isin a stressed condition, and (ii) a second, straight configuration whenthe body is in an unstressed condition;

loading the suture and the anchor into a sheath so that the anchorassumes its first folding configuration;

passing the sheath into the capsule of a joint;

pushing the anchor through the sheath and into the capsule of the jointso that as the anchor passes into the joint, the anchor assumes itssecond, straight configuration;

positioning the anchor against the interior surface of the capsule; and

pulling the length of suture proximally so as to retract the capsule ofthe joint.

In another preferred form of the invention, there is provided anapparatus for retracting a capsule of a joint, the apparatus comprising:

an elongated rod having a proximal end and a distal end; and

a retraction element disposed on the distal end of the elongated rod.

In another preferred form of the invention, there is provided a methodof retracting a capsule of a joint, the method comprising:

providing an elongated rod having a proximal end and a distal end and aretraction element disposed on the distal end of the elongated rod;

-   -   wherein the retraction element comprises a pivoting distal end,        and further wherein the pivoting distal end may be pivoted        between (i) a first position in which the distal end is aligned        with the longitudinal axis of the elongated shaft, and (ii) a        second position in which the distal end extends at an angle to        the longitudinal axis of the elongated rod;

pivoting the distal end of the elongated rod into the first position;

passing the elongated rod into the capsule of a joint so that the distalend of the elongated rod is positioned within the interior of the joint;

pivoting the distal end of the elongated rod into the second position;

positioning the distal end of the elongated rod against the interior ofthe capsule; and

pulling the elongated rod proximally so as to retract the capsule of thejoint.

In another preferred form of the invention, there is provided a methodof retracting a capsule of a joint, the method comprising:

providing an elongated rod having a proximal end and a distal end and aretraction element disposed on the distal end of the elongated rod;

-   -   wherein the retraction element comprises a projection, and        further wherein the projection may be moved between (i) a first        position in which the projection is aligned with the        longitudinal axis of the elongated shaft, and (ii) a second        position in which the projection extends at an angle to the        longitudinal axis of the elongated rod;

moving the projection into the first position;

passing the elongated rod into the capsule of a joint so that the distalend of the elongated rod is positioned within the interior of the joint;

moving the projection into the second position; and

positioning the elongated rod against the interior of the capsule andpositioning the projection of the elongated rod against the neck of thefemur so as to retract the capsule of the joint.

In another preferred form of the invention, there is provided a methodof retracting a capsule of a joint, the method comprising:

providing an elongated rod having a proximal end and a distal end, thedistal end comprising a retraction element;

-   -   wherein the retraction element comprises a corkscrew;

passing the elongated rod into the capsule of a joint so that the distalend of the elongated rod is positioned on the capsule;

rotating the elongated rod so as to pass the corkscrew through thecapsule; and

pulling the elongated rod proximally so as to retract the capsule of thejoint.

In another preferred form of the invention, there is provided a methodof retracting a capsule of a joint, the method comprising:

providing a length of suture and an anchor attached to one end of thelength of suture;

loading the suture and the anchor into a sheath;

passing the sheath into the capsule of a joint;

pushing the anchor through the sheath into the capsule of the joint sothat the anchor is positioned on the interior of the capsule, with thesuture extending from the anchor; and

pulling the length of suture proximally so as to retract the capsule ofthe joint.

In another preferred form of the invention, there is provided a methodof retracting a capsule of a joint and maintaining the retraction of thecapsule of the joint, the method comprising:

providing a length of suture;

providing a cannula having a distal end for positioning in the joint anda proximal end comprising a projection for securing a length of suture;

passing the length of suture through the capsule of the joint so thattwo free ends of suture extend through the cannula;

pulling the length of suture proximally so as to retract the capsule ofthe joint; and

securing the length of suture around the projection so as to maintainthe retraction of the capsule of the joint.

In another preferred form of the invention, there is provided a methodof retracting capsule of a joint, the method comprising:

providing an elongated rod having a proximal end and a distal end, thedistal end comprising a hook;

forming a cut in the capsule;

passing the hook of the elongated rod under one side of the cut capsule;and

pulling the elongated rod proximally so as to retract the capsule.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects and features of the present invention will bemore fully disclosed or rendered obvious by the following detaileddescription of the invention, which is to be considered together withthe accompanying drawings wherein like numbers refer to like parts andfurther wherein:

FIG. 1 is a simplified cross-sectional view of a hip joint;

FIG. 2 is a simplified cross-sectional view of a hip joint undergoing aprior art method for distracting a femoral head from an acetabulum:

FIG. 3 is a simplified cross-sectional view of a hip joint;

FIG. 4A is a cross-sectional view of a system for accessing the capsuleof a joint, according to an embodiment of the invention;

FIGS. 4B-4F are cross-sectional views of a hip joint being accessed by asystem for accessing the capsule of a joint, according to an embodimentof the invention;

FIGS. 5A and 5B are cross-sectional and side views of a system foraccessing the capsule of a joint, according to an embodiment of theinvention;

FIGS. 5C-5F are partial cross-sectional views of a hip joint beingaccessed by a system for accessing the capsule of a joint, according toan embodiment of the invention;

FIG. 6A is a side cross-sectional view of a system for accessing thecapsule of a joint, according to an embodiment of the invention;

FIGS. 6B and 6C are longitudinal cross-sectional and partial side views,respectively, of a system for accessing the capsule of a joint,according to an embodiment of the invention;

FIG. 6D is a longitudinal cross-sectional view of a system for accessingthe capsule of a joint, according to an embodiment of the invention;

FIG. 6E is a partial perspective view of a grasping device, according toan embodiment of the invention;

FIG. 6F is a partial side view of a system for accessing the capsule ofa joint, according to an embodiment of the invention;

FIG. 6G is a side view of a system for accessing the capsule of a joint,according to an embodiment of the invention;

FIGS. 7A and 7B are side and longitudinal cross-sectional views,respectively, of a system for accessing the capsule of a joint,according to an embodiment of the invention;

FIGS. 8A and 8B are side-perspective and cross-sectional views,respectively, of a system for accessing the capsule of a joint,according to an embodiment of the invention;

FIGS. 9A-9C are partial side views of a system for accessing the capsuleof a joint, according to an embodiment of the invention;

FIG. 10A is a partial side cross-sectional view of a system foraccessing the capsule of a joint, according to an embodiment of theinvention;

FIG. 10B is partial side views of grasping devices, according toembodiments of the invention;

FIGS. 10C and 10D are longitudinal cross-sectional and partial sideviews, respectively, of a system for accessing the capsule of a joint,according to an embodiment of the invention;

FIGS. 11A and 11B are side views of systems for distending a capsule ofa joint, according to embodiments of the invention;

FIG. 11C is a partial cross-sectional view of a hip joint beingdistended by a system for distending a capsule of a joint, according toan embodiment of the invention;

FIGS. 12A-12E are partial side views of systems for distending a capsuleof a joint, according to embodiments of the invention;

FIG. 13A is a cross-sectional view of a device for distending a capsuleof a joint, according to an embodiment of the invention;

FIG. 13B is a side view of a system for distending a capsule of a joint,according to an embodiment of the invention;

FIG. 13C is a partial cross-sectional view of a hip joint beingdistended by a device for distending a capsule of a joint, according toan embodiment of the invention;

FIG. 14A is a cross-sectional view of a system for distending a capsuleof a joint, according to an embodiment of the invention;

FIG. 14B is a partial cross-sectional view of a hip joint beingdistended by a system for distending a capsule of a joint, according toan embodiment of the invention;

FIG. 15A is a side view of a system for distending a capsule of a joint,according to an embodiment of the invention;

FIGS. 15B-15F are partial cross-sectional views of a hip joint beingdistended by a system for distending a capsule of a joint, according toan embodiment of the invention;

FIGS. 16-19 are schematic views of a locking access cannula, accordingto an embodiment of the invention;

FIGS. 20-24 are schematic views of a method of using the access cannulaof FIGS. 16-19:

FIG. 25 is a schematic view of a tensioning access cannula, according toan embodiment of the invention;

FIGS. 26 and 27 are schematic views of a method of using the tensioningaccess cannula of FIG. 25;

FIGS. 28A-28E are schematic views of a device for retracting the capsuleof a joint, according to an embodiment of the invention;

FIGS. 28F-28I are schematic views of a method of using the device ofFIGS. 28A-28E to retract the capsule of a joint, according to anembodiment of the invention;

FIGS. 29 and 29A-29D are schematic views of a device for retracting thecapsule of a joint, according to an embodiment of the invention;

FIGS. 29E and 29F are schematic views of a method of using the device ofFIGS. 29 and 29A-29D to retract the capsule of a joint, according to anembodiment of the invention;

FIG. 30 is a schematic view of a device for retracting the capsule of ajoint, according to an embodiment of the invention;

FIGS. 30A and 30B are schematic views of a method of using the device ofFIG. 30 to retract the capsule of a joint, according to an embodiment ofthe invention;

FIG. 31 is a schematic view of a device for retracting the capsule of ajoint, according to an embodiment of the invention;

FIGS. 31A-31C are schematic views of a method of using the device ofFIG. 31 to retract the capsule of a joint, according to an embodiment ofthe invention;

FIG. 32 is a schematic view of a device for retracting the capsule of ajoint, according to an embodiment of the invention;

FIGS. 33-38B are schematic views of a method of using the device of FIG.32 to retract a capsule of a joint, wherein FIGS. 35 and 38 areschematic views taken from the outside of the capsule;

FIGS. 39-48 are schematic views of a method of using the device of FIG.32 to close the capsule of a joint, wherein FIGS. 39-44 and 46-47B arecross-sectional views of the joint and FIGS. 45, 47C and 48 areschematic views taken from the outside of the capsule; and

FIGS. 49 and 50 are schematic views of devices for retracting a capsuleof a joint, according to an embodiment of the invention.

DETAILED DESCRIPTION OF THE INVENTION

Devices and methods are disclosed herein for accessing the hip joint.The devices described herein can provide safely made portals within thecapsule for access to the peripheral compartment by other devices. Forexample, the devices described herein generally provide access to theperipheral compartment by grasping and securely engaging the capsulewith a first device, typically a cannula or sheath. The first device issecured enough to enable the first device to pull the capsule away fromthe joint and “tent” of the capsule. Tenting the capsule creates alarger volume within the peripheral compartment. A second device,typically a needle, can then be biased against the first device to applya piercing force against the tented capsule. The use of counter-tractionagainst the first device allows the second device to be advanced intothe capsule in a controlled manner to avoid “popping” uncontrollablyinto the peripheral compartment. Tenting of the capsule also provides anadditional safety margin by providing extra space between the capsuleand the tissue beyond it for the second device to traverse. The devicesand methods herein do not require the use of a traction table to safelypierce the capsule.

Devices and methods are also disclosed herein for distending the capsuleof a joint to enlarge the working area within the peripheralcompartment. For example, a distension device can access the peripheralcompartment after a safely made portal has been established as describedherein. A distension device can then apply an expansive force within theperipheral compartment to distend and stretch the capsule. Accordingly,the peripheral compartment becomes enlarged which allows for betteraccess by other surgical devices. In some embodiments, the distensiondevice can continually distend the peripheral compartment while otherdevices access the joint. Distension of the capsule can allow for fewerportals to be established into the capsule, as greater working space iscreated. It should be understood that the devices of the invention maybe useful for access into other joints besides the hip, such as theshoulder, knee, or ankle. It should also be understood that devices ofthe invention are useable in conjunction with visual guidance systemssuch as fluoroscopy and arthroscopy systems.

FIG. 1 illustrates the basic anatomy of a hip joint. The hip joint isformed between the head of the femur FH and the acetabulum A, a concavesurface of the pelvis. The acetabular fossa AF is a recessed region inthe acetabulum. A blanket of ligaments covers the joint forming acapsule C. Additionally, the acetabular labrum L, a fibrocartilaginouslip, surrounds the head of the femur, deepens the joint pocket andincreases the surface area of contact. Labrum L divides the hip jointinto two compartments within the joint capsule: a central compartment CCand a peripheral compartment PC. Central compartment CC is within theconfines of labrum L and contains the majority of the joint cartilageand the ligamentum teres LT, a ligament attached to a depression in theacetabulum (the acetabular notch or fossa) and a depression on thefemoral head (the fovea of the head). Peripheral compartment PC iseverything outside the labrum and within the capsular ligaments C. Thecentral compartment CC is generally not visible until the joint has beendistracted.

FIG. 2 illustrates how traction 204 is conventionally applied to apatient's leg and against a post 202 positioned against the perineumregion to distract femoral head FH away from acetabulum A, therebycreating a space 206 between the two joint surfaces. This space 206allows a surgeon to access the joint and perform diagnostic ortherapeutic procedures.

FIG. 3 illustrates some of the possible entry portals for deliveringinstruments into the hip joint. FIG. 3 is a top view of a hip joint inwhich femoral head FH rests against acetabulum A. The joint space iscovered by capsule C and labrum L. Access into the joint may be obtainedby introducing instruments through a posterolateral portal PLP along aside and posterior to the joint or an anterolateral portal ALP along aside and anterior to the joint.

Peripheral Compartment Access

FIG. 4A illustrates a system 400 for accessing the capsule of a joint.The system 400 includes an elongated needle 402. As used herein,“needle” may encompass various devices for penetrating the capsulartissue, and is meant to include a variety of puncturing devicesincluding, for example, trocars, coring (hollow) needles, non-coring(solid) needles, and stylet/needle combinations, as well as blunt-tippedinstruments such as dilators or tubular devices. Needle 402 may be acommercially available 18-27 gauge spinal needle. Needle 402 may beconstructed from a metal (e.g., stainless steel) or a polymer. Needle402 may include one or more lumens fluidly connected to one or moreopenings in or near a distal tip 404. Distal tip 404 may include one ormore bevels. Needle 402 may include a sensor, such as a strain gauge orload cell, functionally coupled to an interior or exterior portion ofthe needle.

Needle 402 may include an enlarged proximal member 406. Enlargedproximal member 406 may be a comparatively enlarged mass of material(e.g., a flange) with respect to a central portion 408 of needle 402.Proximal member 406 and/or central portion 408 may include threadedportions. Proximal member 406 may also be a fluidic connector, such as aLuer connector, in fluid communication with one or more lumens andrespective distal openings. If a sensor is included with the needle, thesensor may be electrically connected to an electrical connector ofproximal member 406.

System 400 also includes a cannula or elongated sheath 410. Sheath 410includes a cylindrical body 412 with an inner surface 414. Inner surface414 may be diametrically sized to enable needle 402 and sheath 410 tofreely slide with respect to each other along longitudinal directionA-A. Inner surface 414 may include threads 415 which may threadablyengage with a portion of needle 402. Inner surface 414 may bediametrically sized to allow other cylindrical devices, such ascannulas, sheaths, stents, etc., to fit between needle 402 and innersurface 414. Inner surface 414 may have a diameter ranging from 2 to 15millimeters. Sheath 410 may be constructed from a metal (e.g., stainlesssteel) or a polymer. Sheath 410 includes a proximal flange 416 whichextends circumferentially from cylindrical body 412. Sheath 410 may havean overall length of 50 to 150 millimeters.

A distal end 418 of sheath 410 includes a plurality of grasping members420. Sheath 410 includes at least two opposed grasping members 420, andmay include more (e.g., 3 to 20) grasping members 420. Grasping members420 are circumferentially spaced with respect to cylindrical body 412 inan even manner. Grasping members 420 may extend in an approximate radialdirection B-B, which is tangent to directions A-A, from cylindrical body412. Grasping members 420 may also extend in an approximate tangentialdirection C-C, which is tangent to directions A-A and B-B, fromcylindrical body 412. The grasping members may also extend in directionsbetween directions A-A, B-B, and C-C.

Grasping members 420 may be configured as hooks or barbs. Graspingmembers 420 may fixedly extend from distal end 418 or be retractable andextendable within or along proximal end 418. Portions of graspingmembers 420 may slidably extend within cylindrical body 412 to proximalflange 416. Grasping members 420 may be constructed from a metal (e.g.,stainless steel, shape-memory or super elastic nitinol (Ni—Ti)) or apolymer. Grasping members 420 may be part of a greater structure, suchas a sheath or stent, internally or externally coupled to sheath 410.

FIGS. 4B-4F illustrate a method of use for system 400, for accessing andpenetrating the capsule of a joint. In FIG. 4B, an incision is made inthe skin and needle 402 is used to penetrate the outer tissuesurrounding capsule C. Needle 402 may be placed in various portal accesslocations, such as the anterolateral, distal-anterolateral and anteriorlocations. Needle 402 is then maintained at the surface of the capsule.Optionally, needle 402 may partially or fully penetrate the capsulartissue.

In FIG. 4C, sheath 410 is advanced over needle 402 to the surface ofcapsule C. In FIG. 4D, grasping members 420 engage capsule C bypenetrating into capsule C to securely attach sheath 410. Graspingmembers 420 may engage capsule C by actuation of grasping members 420 atproximal flange 416 and/or by physical manipulation (e.g., rotating orpushing) of cylindrical body 412. Needle 402 may be replaced by adifferent needle more suitable for penetrating capsule C, such as aspecialized trocar, or an additional cutting sheath may supplementneedle 402, for example by inserting the cutting sheath between needle402 and sheath 410.

In FIG. 4E, sheath 410 is pulled away from the joint as shown by thedirectional arrows and maintained in that position. This causes capsuleC to tent away from femoral head FH and increase the volume ofperipheral compartment PC.

In FIG. 4F, needle 402 is used to penetrate capsule C. Needle 402 isadvanced while sheath 410 tents capsule C by pulling sheath 410 awayfrom femoral head FH. Needle 402 is unlikely to damage tissue underneathcapsule C, as a significant gap is created between capsule C and femoralhead FH. Accordingly, “popping” through capsule C and damaging tissuebeyond is minimized. Needle 402 may threadably engage sheath 410, and beturned to advance through capsule C, which results in a controlled rateof penetration. If a sensor is present on needle 402, the sensor canprovide an electrical signal to an indication system which indicatespenetration of capsule C by a visual or aural indicator. Optionally, adistention fluid, such as saline, may be injected into peripheralcompartment PC through needle 402 to distend capsule C.

FIGS. 5A and 5B illustrates another system 500 for accessing the capsuleof a joint. System 500 includes a tear away cannula or sheath 502.Sheath 502 is similarly configured to sheath 410. Sheath 502 has aninner lumen 504 in which is placed an expansion device 506, which isshown partially extending from sheath 502 (not shown). Before use,expansion device 506 is completely withdrawn within sheath 502.Expansion device 506 may be constructed similarly to a stent. Expansiondevice 506 includes a plurality of struts 508 connected by a pluralityof expandable members 510. A plurality of grasping members 512configured as tangential hooks are connected to struts 508. Otherconfigurations of grasping members 512 may be used, as disclosedelsewhere herein. Expansion device 506 may be constructed from a metal,such as a shape memory or super elastic Ni—Ti, or a stainless steel.

FIG. 5B shows system 500 in an expanded configuration. A second cannulaor sheath 514 is configured to slidably fit within expansion device 506.Expansion device 506 may be diametrically sized in an expandedconfiguration such that sheath 502 may be used as second sheath 514. Atrocar 516 is slidably coupled with sheath 514. Trocar 516 includes acutting tip 518. Cutting tip 518 may have a pyramid shape with aplurality of sharpened edges 520. Stylet 522 is slidably coupled withintrocar 516. Stylet 522 includes a blunt distal tip 524 which extendspast cutting tip 518.

FIGS. 5C-5F illustrate a method of use for system 500, for accessing andpenetrating the capsule of a joint. In FIG. 5C, sheath 502 has beenslightly withdrawn to expose grasping members 512 of expansion device506. Grasping members 512 fixedly engage with capsule C by rotating theexposed grasping members 512 into capsule C. Needle 402 is then advancedrelative to sheath 502 to puncture capsule C while sheath 502 tentscapsule C by pulling sheath 502 away from femoral head FH. Graspingmembers 512 may exude a diametric expansion force on the capsule toexpand and maintain the puncture site. Needle 402 may be used to injectcapsule C with saline 530 to pressurize and distend capsule C. Needle402 and sheath 502 may then be withdrawn from system 500.

In FIG. 5D, expansion device 506 is fully expanded after sheath 502 hasbeen removed. Stylet 522 is exchanged with needle 402 to enlarge andmaintain the opening created by needle 402. Blunt distal tip 524prevents damage to tissue beyond capsule C.

In FIG. 5E, sheath 514 and trocar 516 are introduced over stylet 522 andthrough expansion device 506. In FIG. 5F, sheath 514 and trocar 516 areadvanced to penetrate capsule C. Prior puncturing of capsule C by needle402 and stylet 522 allows trocar 516 to easily penetrate capsule C andexpand the opening. Blunt distal tip 524 of stylet 522 prevents damageto tissue beyond capsule C, while trocar 516 is advanced. Trocar 516 andstylet 522 may then be removed to allow access by other devices throughsheath 514.

FIG. 6A illustrates a cannula or sheath 600, which may be used inconjunction with the systems disclosed herein. Sheath 600 includes acylindrical body 602, a plurality of pathways 604 and a flange 606. Adistal end 607 of cylindrical body 602 may be tapered. Pathways 604extend axially within the sidewall of sheath 600 from its proximal endto its distal end. Sheath 600 may be constructed from a metal or apolymer material. Sheath 600 may be constructed as an expandable stentand include expandable zones between pathways 604. Pathways 604 may becircular or rectangular lumens.

A plurality of grasping members 610 are slidably housed within pathways604. Grasping members 610 may comprise elongated needles with precurveddistal ends 612. Distal ends 612 may be precurved to extend as hooks inan approximate inward or outward radial direction, tangential direction,or directions therebetween. Grasping members 610 may include respectiveproximal flanges 614. Proximal flanges 614 may be connected to eachother by e.g., a ring-shaped member or slide independently from eachother. Grasping members 610 may be constructed from a metal (e.g.,stainless steel, shape-memory or super elastic Ni—Ti) or a polymer.Grasping members 610 may have circular or rectangular cross-sections.

In use, sheath 600 is used for securing to a capsule in accordance withthe methods disclosed herein. Distal ends 612 of grasping members 610may secure to the capsule by moving proximal flanges 614 in a distaldirection such that distal ends 612 of grasping members 610 extend frompathways 604 and assume a precurved hook shape to securely engagecapsule C. Distal ends 612 of grasping members 610 may disengage fromcapsule C by moving proximal flanges 614 in a proximal direction awayfrom flange 606 of sheath 600. Accordingly, distal ends 612 of graspingmembers 610 will disengage from capsule C and withdraw back intopathways 604.

FIGS. 6B and 6C illustrate a sheath 600 b according to an alternativeconstruction of sheath 600. Sheath 600 b includes a plurality ofcircumferentially expandable members 616 connected to axial struts 618.Struts 618 may house pathways 604 through which grasping members 610(shown in FIG. 6A) slidably extend. Alternatively, precurved distal ends612 may be welded or otherwise fixed to the distal ends of axial struts618. Sheath 600 b may be constructed from a malleable, elastic,super-elastic, or shape-memory material biased into a radially expandedconfiguration.

In use, sheath 600 b may be used as described with respect to sheath600. Sheath 600 b may first engage capsule C and then apply tension tocapsule C by expanding expandable members 616. Sheath 600 b may alsocombine the functionality of expansion device 506 and sheath 514, and beused in a similar manner to expand and maintain a passage in capsule C.Alternatively, sheath 600 b may be placed within a tubular cannula orportal and allowed to expand against the inner wall thereof to hold itin place. Precurved distal ends 612 may extend distally of the distalend of sheath 600 b and be used to grasp the capsular tissue to retainthe cannula therein. Expandable members 616 may alternatively be amalleable material and expanded by applying internal force to sheath 600b, for example by expanding a balloon therein. Alternatively, expandablemembers 616 may be expanded by applying heat, in the case ofshape-memory material, or by disengaging from a constrainedconfiguration, in the case of an elastic or super-elastic material.

FIGS. 6D-6F illustrate a sheath 600 c according to an alternativeconstruction of sheath 600. Sheath 600 c includes an extrudedcylindrical body 602 c with a plurality of longitudinal pathways 604 cconfigured in cross-section as rectangular slots. Pathways 604 c have anapproximately rectangular cross-section and are partially open along theouter surface of cylindrical body 602 c. Pathways 604 c slidably house aplurality of grasping members 610 c (FIGS. 6E and 6F).

Grasping members 610 c are constructed from flattened wire and includeprecurved distal ends 612 c. Precurved distal ends 612 c are configuredas flattened hooks.

In use, sheath 600 c may be used as described with respect to sheath600.

FIG. 6G illustrates a sheath 600 e according to an alternativeconstruction of sheath 600. Sheath 600 e shares the general constructionof sheath 600. Sheath 600 e includes a proximally located threadedsection 620 on a cylindrical body 602 which threadably couples to a cap622. Grasping members 610 are joined by a proximally located ring 624,which is proximal to threaded section 620. A compression spring may becoupled between threaded section 620 and ring 624. Cap 622 may have aproximal opening. Cap 622 is diametrically sized to fit over and to berotatable relative to ring 624. Cap 622 may be coupled to ring 624 sothe two move axially together as the cap is screwed in. Cap 622 maycomprise a shaped knob. A flange may be distally located from threadedsection 620 on cylindrical body 602. The cap may be turned manually, oran electrical motor, control circuitry, and user interface may befunctionally coupled to drive cap 622.

In use, sheath 600 e may be used as described with respect to sheath600. Cap 622 is coupled to threaded section 620 and turned, which causescap 622 to move in a distal direction. As cap 622 is turned, it willeventually contact ring 624, or if cap 622 is fixedly attached to ring624, cap 622 and ring 624 will move in unison. Accordingly, cap 622moves ring 624 in the distal direction while being turned to causegrasping members 610 to move within pathways 604, and eventually causedistal ends 612 of grasping members 610 to extend out of cylindricalbody 602 and engage capsule C. Cap 622 may be turned to move in aproximal direction to cause grasping members 610 to withdraw intocylindrical body 602 and disengage from capsule C. While distal ends 612are shown as being precurved inwardly, they may also be precurved in aradially-outward direction, or in a tangential direction.

FIGS. 7A and 7B illustrate a system 700 for accessing the capsule of ajoint. System 700 includes a cannula or sheath 702, generallyconstructed as the sheaths disclosed herein. Sheath 702 includes acylindrical body 704 and a flange 706. Sheath 702 may include aproximally located threaded section 708.

An expansion device 710 is disposed within the inner lumen of sheath702. Expansion device 710 includes a plurality of grasping members 714which are biased radially inwardly. Grasping members 714 includeelongated axial shafts 715 and respective distal ends 716 locatedexternally to sheath 702 at the distal end thereof. Distal ends 716 ofgrasping members 714 may be configured as L-shaped hooks arranged topoint radially outwardly. Grasping members 714 may be malleable, orresilient and biased radially inwardly. Proximal sections 718 ofgrasping members 714 may be fixedly attached to inner surface 712 ofcylindrical body 704 of sheath 702, or grasping members 714 may beinterconnected to create a tubular structure removably positionable inthe lumen of sheath 702.

An inner shaft 720 is slidably disposed within expansion device 710.Inner shaft 720 is constructed as an elongated tube. Inner shaft 720 caninclude a threaded section 722 which threadably couples with threadedsection 708 of sheath 702. Alternatively, inner shaft 720 can freelyslide within sheath 702.

Inner shaft 720 includes a flange 724, which may be configured as aknob. In use, system 700 can generally be used with a needle asdescribed in the methods disclosed herein. The distal tip of sheath 702is first advanced through a penetration in the capsule, which may beformed using a needle or trocar point placed through the inner lumen ofinner shaft 720. Sheath 702 may then be securely attached to the capsuleby advancing inner shaft 720 with respect to sheath 702. Turning flange724 causes threaded section 722 to move in a distal direction, or in thecase where no threaded sections are present, flange 724 can be simplyslid towards flange 706. Distal movement of inner shaft 720 eventuallycauses inner shaft 720 to displace grasping members 714 radiallyoutwardly. In turn, distal ends 716 expand in a radial direction tosecurely engage the interior wall of the capsule C.

FIGS. 8A and 8B illustrate a cannula construction which may be used inconjunction with the systems disclosed herein. Sheath 800 includes aplurality of fixedly and distally attached grasping members 802.Grasping members 802 are configured as inwardly spring-biased hooks, asshown in FIG. 8A. Grasping members 802 may be constructed from aresilient, shape memory or super-elastic material, such as Ni—Ti. Aninner tube 804 is slidably disposed within sheath 800, and outwardlydisplaces grasping members 802 in one configuration as shown in FIG. 8B.

In use, sheath 800 can generally be used in the manner describedelsewhere in connection with the methods disclosed herein. Sheath 800securely attaches to a capsule of a joint by withdrawing inner shaft 804with respect to sheath 800. Proximal movement of inner shaft 804 allowsgrasping members 802 to move from the configuration shown in FIG. 8B tothe configuration shown in FIG. 8A. Accordingly, when inner shaft 804releases grasping members 802, grasping members 802 securely engagecapsule C. A needle or other instrument can then be inserted throughsheath 800 to puncture capsule C.

FIGS. 9A-9C illustrate a cannula construction which may be used inconjunction with the systems disclosed herein. An elongated stent 900includes a plurality of struts 902 and resilient circumferentiallyexpandable and contractible bands 904. Struts 902 include a plurality ofrespective grasping members 906 configured as inwardly spring-biasedhooks, as shown in FIG. 9A. Elongated stent 900 may be constructed froma super-elastic material, such as Ni—Ti. Elongated strut 900 is coupledto a cannula or sheath 908. Sheath 908 is generally constructed as thesheaths disclosed herein. A plurality of travel limiters 910 may extendfrom sheath 908. Elongated stent 900 is biased into a radiallycontracted configuration and is coupled to sheath 908 by forciblyexpanding elongated stent 900 and inserting sheath 908 therein, as shownin FIG. 9B. Accordingly, elongated stent 900 securely holds onto sheath908.

In use, grasping members 906 securely attach to the capsule of a jointby placing sheath 908 into contact with the outer surface of thecapsule, and advancing elongated stent 900 relative to sheath 908. Whengrasping members 906 have cleared the distal end of sheath 908, graspingmembers 906 are allowed to move from the configuration shown in FIG. 9Bto the configuration shown in FIG. 9C. Accordingly, when sheath 908releases grasping members 906, grasping members 906 securely engagecapsule C. Travel limiters 910 prevent further movement of elongatedstent 900 with respect to sheath 908. A needle or other instrument canthen be placed through sheath 908 to puncture capsule C and performprocedures therein.

FIGS. 10A-10D illustrate a cannula construction which may be used inconjunction with the systems disclosed herein. A cannula or sheath 1000includes an elongated inner tube 1005 including a plurality of radialarranged grasping members 1010 extending therefrom. Grasping members1010 may be constructed from a resilient or malleable material andinclude tapered, straight/flat, or duckbill configurations as shown fromtop to bottom in FIG. 10B. An outer tube 1015 is rotatably engaged overinner tube 1005. Outer tube 1015 includes a plurality of slots 1020(FIG. 10D) which are slidably engaged with grasping members 1010. Outertube 1015 is diametrically sized to fit over inner tube 1005 androtationally movable from a first position in which grasping members1010 are radially collapsed, as shown in FIG. 10A, to a second positionin which grasping members 1010 are radially extended, as shown in FIGS.10C and 10D. Outer tube 1015 and inner tube 1005 can include a lockingmechanism, such as a button extending from inner tube 1005 which locksinto an opening of outer tube 1015, for maintaining the configurationshown in FIG. 10D.

In use, sheath 1000 can generally be used with a needle as described inthe methods disclosed herein. Sheath 1000 is placed against the capsuleand a needle may be positioned through sheath 1000 to puncture capsuleC. The tip of sheath 1000 is then inserted into the capsule. Graspingmembers 1010 securely attach to capsule C of a joint by rotating innertube 1005 and outer tube 1015 with respect to each other. Accordingly,either inner tube 1005 or outer tube 1015 is held stationary, and theother is rotated. This action causes grasping members 1010 to extendfrom slots 1020 and securely engage the inner surface of capsule C.Rotating either inner tube 1005 or outer tube 1015 back into itsoriginal position causes grasping members 1010 to withdraw back intosheath 1000 and disengage from capsule C.

Capsular Distention

Further embodiments of the invention include distension devices whichare used to distend capsule C and enlarge peripheral compartment PC. Itshould be understood that the distension devices disclosed herein can beused with any of the systems disclosed herein to access capsule C.

FIG. 11A illustrates a system 1100 for accessing and distending thecapsule of a joint. System 1100 includes a cannula or sheath 1102, whichis configured similarly to the sheaths disclosed herein. An expansiondevice 1104 is coupled within sheath 1102. Expansion device 1104includes a plurality of grasping members 1106 shown in an exposedposition. Expansion device 1104 may generally be configured similarly tothe expansion devices disclosed herein.

A balloon device 1108 is slidably disposed within sheath 1102. Balloondevice 1108 includes an elongated shaft 1110 with a distally positionedballoon 1112. Shaft 1110 may be constructed from a flexible or stiffmaterial, such as a metal or polymer. Shaft 1110 may include at leastone lumen. Shaft 1110 can be circular in cross-section and have an outerdiameter sized to be exchangeable with the needles disclosed herein, forexample 18-27 gauge. Balloon 1112 may be constructed from anon-compliant (e.g., 0-10% compliance range) thin-walled material suchas polyethylene terephthalate (PET), or from a semi-compliant (e.g.,10-20% compliance range) thin-walled material, such as PET, nylon, andpolyurethane. Balloon 1112 may be capable of withstanding high pressures(e.g., up to 400 psi), and include reinforcement features, such asintegrated woven fibers, to help prevent bursting. Balloon 1112 can havea wall thickness ranging from 0.0001 to 0.0006 inches, and may also havemultiple layered wall, e.g., 2-ply or 3-ply, with the layers eitheradhered to each other or not. Balloon 1112 is shown in an expandedconfiguration and may have an expanded diameter of 5 to 20 millimeters.Balloon 1112 may be folded or collapsed into an unexpanded configurationto have an effective diameter which is roughly equivalent to or slightlylarger than the outer diameter of shaft 1110. Balloon 1112 may utilizevarious shapes and sizes other than the generally spherical shape shown,such as spherical, donut, cylindrical, oval, curved, conical or kidneyshapes.

An atraumatic tip 1114 extends from balloon 1112. Atraumatic tip 1114can be constructed from a soft material, such as rubber. A connector1116 for coupling to an inflation device, such as a syringe orangioplasty balloon inflation device, is proximally located on shaft1110. Connector 1116 is fluidly coupled to balloon 1112.

FIG. 11B illustrates a system 1100 b for accessing and distending thecapsule of a joint. System 1100 b is largely identical to system 1100except that in system 1100 b, sheath 1102 b has hinged sections 1118 b.Hinged sections 1118 b provide sheath 1102 b with a long configuration,and a short configuration as shown. Hinged sections 1118 b radially andoutwardly expand into flanges in the short configuration. These flangesare configured to engage the outer wall of the capsule while graspingmembers 1106 engage the inner wall to sandwich the capsular walltherebetween, thereby firmly retaining sheath 1102 b. A clip 1120 mayattach to a section 1122 between expansion device 1104 and sheath 1102b, to prevent relative movement therebetween and maintain sheath 1102 bin the short configuration.

FIG. 11C illustrates a method of use for systems 1100, 1100 b, foraccessing and distending the capsule of a joint. In FIG. 11C, system1100 or 1100 b has already been used to puncture capsule C, as similarlydescribed herein. In the case of system 1100 b, hinged sections 1118 bcan be moved to the short configuration to form a flange which holdscapsule C between hinged section 1118 b and grasping members 1106.Balloon device 1108 is then advanced into peripheral compartment PC andballoon 1112 is expanded to distend capsule C. Balloon 1112 can bemaintained in this position over time to stretch capsule C. Accordingly,peripheral compartment PC is enlarged to enable access by other devices.Balloon 1112 may then be deflated and removed from shaft 1110.Alternatively catheters or other devices may be placed through an innerlumen of balloon device 1108, distally of balloon 1112 and into theperipheral or central compartments of the joint to performinterventional procedures therein.

FIG. 12A illustrates a basket device 1200 for distending the capsule ofa joint after accessing the capsule in accordance with systems andmethods described herein. Basket device 1200 includes an elongated shaft1202. Shaft 1202 may be constructed from a flexible or stiff material,including metals or polymers. Shaft 1202 may include at least one lumen.Shaft 1202 can be circular in cross-section and have an outer diametersized to be exchangeable with the needles disclosed herein, for example18-27 gauge. An expandable basket 1204 extends distally from shaft 1202.Basket 1204 includes a plurality of basket leaves 1206 circumferentiallyarranged around shaft 1202. Basket leaves 1206 can be pre-shaped to bowoutwardly, or naturally assume a straightened configuration. Basketleaves 1206 may be constructed from a metal, such as such assuper-elastic Ni—Ti or stainless steel, or from a polymer material. Anatraumatic tip 1208 joins basket leaves 1206 to a pull wire 1210 whichproximally extends within shaft 1202.

FIG. 12B shows an alternatively constructed basket device 1200 b wherepull wire 1210 is positioned outside of shaft 1202.

In use, basket device 1200 or 1200 b may be used to distend capsule C ina similar manner to balloon device 1108 of systems 1100 and 1100 b.Basket 1204 is advanced within a cannula or sheath 1212 and intoperipheral compartment PC. Pull wire 1210 is then pulled proximally withrespect to shaft 1202 to expand basket leaves 1206 and distend capsuleC. In the case where basket 1204 is pre-shaped, pull-wire 1210 isinitially moved distally with respect to shaft 1202 to collapse basketleaves 1206 so that basket 1204 can be advanced down sheath 1212 andinto peripheral compartment PC. Pull wire 1210 is then released (orpulled proximally) to expand basket leaves 1206 and distend capsule C.Other devices may access peripheral compartment PC through shaft 1202.

FIGS. 12C and 12D illustrate a basket device 1200 c for distendingcapsule C. Basket device 1200 c comprises a tubular shaft 1214 and anexpandable basket 1204 coupled to its distal end. Basket 1204 comprisesa plurality of elongated leaves 1206 or tines of a resilient materialfixed at their proximal ends to the inner surface 1202 of shaft 1214.Shaft 1214 includes a cutout portion 1216 in its sidewall near thedistal end thereof configured to receive a second shaft, cannula, orinstrument introduced from a laterally offset location as describedbelow. A pull wire 1210 is fixed at its distal end to the distal end ofbasket 1204 and extends proximally through the interior of shaft 1214.Exerting tension on pull wire 1210 causes leaves 1206 to bow outwardlyinto a radially expanded configuration.

In use, basket device 1200 c is advanced through a penetration in thecapsule to insert basket 1204 inside capsule C, as shown in FIG. 12D.Basket 1204 may then be expanded to distend the capsule. A sheath,cannula, or other instrument 1212 may then be introduced alongside shaft1214 and positioned through cutout portion 1216 so that the distal endof instrument 1212 is within the expanded basket 1204. Cutout portion1216 allows shaft 1214 and instrument 1212 to be arranged at arelatively shallow angle with respect to each other. Other devices canbe inserted through instrument 1212 to perform procedures in theperipheral or central compartments while basket device 1200 c maintainsdistension of capsule C.

FIG. 12E illustrates a basket device 1200 d for distending a capsule.Basket device 1200 d includes a plurality of basket leaves 1206 whichare pre-shaped into basket 1204, as shown. A distal ring 1218 distallyjoins basket leaves 1206, while a proximate ring 1220 proximally joinsbasket leaves 1206. An elongated shaft 1222 is removably coupled todistal ring 1218 and slides within proximate ring 1220. A lockingmechanism can be functionally coupled to proximate ring 1220 and shaft1222 to lock proximate ring 1220 and shaft 1222 to each other.Alternatively, basket leaves 1206 may be normally biased into a straightconfiguration and bowed outwardly by exerting tension on shaft 1222.

In use, shaft 1222 is moved distally with respect to proximate ring 1220to cause basket 1204 to unbow and move towards shaft 1222. This positionreduces the effective diameter of basket 1204 and allows basket device1200 d to be advanced into instrument 1212 (shown in FIGS. 12A. 12B and12D) and into peripheral compartment PC. Once basket 1204 is withinperipheral compartment PC, shaft 1222 is moved proximally with respectto proximate ring 1220 which causes basket 1204 to bow and expandperipheral compartment PC. Shaft 1222 can then be removed frominstrument 1212. Accordingly, as the interior of instrument 1212 isunoccupied by shaft 1222, other devices can simultaneously be insertedinto instrument 1212 while basket device 1200 d maintains distension ofcapsule C. Optionally, shaft 1222 may be tubular so as to allow theintroduction of catheters or instruments therethrough.

FIGS. 13A and 13B illustrate a piston device 1300 for distending thecapsule of a joint. Piston device 1300 includes an elongate body 1302.Elongate body 1302 can house a pneumatic or hydraulic cylinder 1304 orelectrical motor, such as a step-motor. Pneumatic cylinder 1304 ismoveable within elongate body 1302 and is also fluidly sealed therein. Amoveable shaft 1306 extends from pneumatic cylinder 1304 and elongatebody 1302. Moveable shaft 1306 has a range of motion between a fullyextended position and a fully unextended position. Atraumatic bumpers1308 are connected to one end of moveable shaft 1306 and to one end ofelongate body 1302. A pressure hose 1310 is fluidly connected toelongate body 1302. Alternatively, an electrical cable can be connectedto elongate body 1302 if an electrical motor is housed therein. Anelongated applicator device 1312 is detachably coupled to one of theatraumatic bumpers 1308 at a distal cup 1314. A push rod 1316 ismoveably housed within applicator device 1312 and can moveably extendinto distal cup 1314.

FIG. 13C illustrates a method of use for piston device 1300 to distendcapsule C of a joint. In FIG. 13C, capsule C has already been puncturedin accordance with the methods disclosed herein. Applicator device 1312is advanced into a sheath to deposit piston device 1300 withinperipheral compartment PC. Actuation of push rod 1316 detaches pistondevice 1300 from distal cup 1314. Piston device 1300 may be placedwithin peripheral compartment PC, so that atraumatic bumpers 1308 arepositioned at capsule C and greater trochanter T, or at capsule C andfemoral neck FN, or in various other positions. Pressure hose 1310 iscoupled to a pressure source and pressurized. Accordingly, the increasedpressure causes pneumatic cylinder 1304 to move moveable shaft 1306 tothe fully extended position and distend capsule C between atraumaticbumpers 1308. Alternatively, an electrical signal is sent to pistondevice 1300, if an electrical motor is used, to move moveable shaft 1306to the fully extended position and distend capsule C between atraumaticbumpers 1308.

FIG. 14A illustrates a distention device 1400 for distending the capsuleof a joint. Distention device 1400 includes an elongate shaft 1402. Anatraumatic foot 1404 is distally connected to shaft 1402. Atraumaticfoot 1404 may be curved to fit the profile of portions of a joint, suchas femoral neck FN. Shaft 1402 includes a threaded section 1406 which isthreadably coupled to a knob 1408. Knob 1408 is rotatably coupled to asheath 1410. Sheath 1410 can assume the general construction of sheathsdisclosed herein.

FIG. 14B illustrates a method of use for distention device 1400 todistend capsule C of a joint. In FIG. 14B, sheath 1410 has been securelyattached to capsule C. and capsule C has already been punctured inaccordance with the methods described herein. Shaft 1402 is advancedwithin sheath 1410 into peripheral compartment PC to contact atraumaticfoot 1404 against femoral neck FN. Knob 1408 is then rotated until itcontacts and couples with secured sheath 1410. Knob 1408 is continuallyrotated to cause shaft 1402 to move distally with respect to knob 1408and sheath 1410. Accordingly, atraumatic foot 1404 of shaft 1402 pushesagainst femoral neck FN, which causes capsule C to stretch and distendbetween femoral neck FN and secured sheath 1410.

FIG. 15A illustrates a system 1500 for distending the capsule of ajoint. System 1500 includes a first elongated strap 1502 and a secondelongated strap 1504. Straps 1502, 1504 may be constructed from aflexible cord, such as a braided polymer rope. Straps 1502, 1504 mayeach include a stiffening core wire 1506. Core wire 1506 can belaterally stiffer than the braided rope. Core wire 1506 can be comprisedfrom a preshaped, super-elastic alloy to angle a distal portion of eachstrap at a predefined angle, for example 30 to 90 degrees, as shown bythe dotted lines. Straps 1502, 1504 each include a distally connectedmagnetic member 1508 a. 1508 b. The straps are generally identicalexcept for the configuration of the magnetic members 1508 a, 1508 b.Magnetic members 1508 a, 1508 b can be magnets with distally positionedopposite polarities. One magnetic member can be a ferromagneticsubstance such as steel, while the other can be a magnet. Magneticmembers 1508 a, 1508 b can include rare-earth magnets, such as neodymiummagnets. The magnetic members 1508 a, 1508 b are shown configured ascylinders, but can include dissimilar and coupling shapes, such as a cupand ball arrangement. Straps 1502, 1504 are diametrically configured tobe slidable within a cannula or sheath 1510.

FIGS. 15B-F illustrate system 1500 in use for distending capsule C of ajoint. In FIG. 15B, two sheaths 1510 are made to access the peripheralcompartment beyond capsule C. Sheaths 1510 can access the capsule inaccordance with the methods disclosed herein. Capsule C can also bepre-distended in accordance with the methods disclosed herein.

In FIG. 15C, straps 1502, 1504 are respectively advanced within thesheaths into peripheral compartment PC. Straps 1502, 1504 aremanipulated to guide magnetic members 1508 a. 1508 b to unite. Corewires 1506, if present, can aid to steer magnetic members 1508 a, 1508 btowards each other. Once magnetic members 1508 a. 1508 b are guided intogeneral vicinity, a magnetic force will cause them to magneticallycouple to join the two straps. Accordingly, straps 1502, 1504 becomeunited.

In FIG. 15D, strap 1502 is pulled out of its respective sheath 1510.Straps 1502, 1504 are magnetically united which causes strap 1504 tofollow as strap 1502 is pulled. Accordingly, a mid-section of strap 1504is made to occupy peripheral compartment PC. Sheaths 1510 can then beremoved from capsule C.

In FIG. 15E, two guide probes 1512 are advanced into the openings wheresheaths 1510 previously resided. Sheaths 1510, or other sheaths, can beguided over guide probes 1512 to be guided back into the openingsadjacent to strap 1504.

In FIG. 15F, the ends of strap 1504 are pulled away from the joint todistend capsule C, as shown. Tension may be continuously maintained onstrap 1504 by a traction mechanism to maintain capsule C in thedistended position. Other devices may then access peripheral compartmentPC using sheaths 1510 for a following procedure. Strap 1504 may beremoved by discontinuing application of tension and pulling strap 1504out of one the openings. Strap 1504 may be cut at a location near thejoint to aid in removal.

Additional Methods and Apparatus for Accessing the Interior of a HipJoint and Increasing the Workspace Adjacent to the Head of the Femurand/or the Acetabulum During an Arthroscopic Hip Procedure AccessCannula with Capsulary Lock

The present embodiment is directed to a cannula that allows quick accessto the interior of the hip joint while also providing a capsulary lockmechanism for selectively locking the distal end of the cannula withinthe capsule of the hip and/or creating additional workspace at thesurgical site.

Looking next at FIGS. 16-24, there is shown a locking access cannula 5formed in accordance with the present invention. Locking access cannula5 generally comprises a cannula sub-assembly 10 and a lockingsub-assembly 15 for mounting over cannula sub-assembly 10.

More particularly, and looking now at FIGS. 17A and 17B, cannulasub-assembly 10 generally comprises a hollow tube 20 having a distal end25 and a proximal end 30 terminating in a proximal hub 35. Cannulasub-assembly 10 is of the type generally known in the art, in the sensethat it includes a central lumen opening on distal end 25 and proximalhub 35, and may include a seal 40 for selectively sealing the centrallumen and/or a luer lock 45 for introducing or removing fluid from thesurgical site. Preferably cannula sub-assembly 10 includes a cannulatedobturator 50 for selectively filling the lumen of hollow tube 20, e.g.,when locking access cannula 5 is inserted into the body. Cannulasub-assembly has windows 47 formed therein (FIG. 17A) for receiving afinger of locking sub-assembly 15, which will hereinafter be discussedin further detail.

Locking sub-assembly 15 (FIGS. 18 and 19) comprises a sleeve 55 havingan expandable collar 60 on its distal end, and a housing 65 whichincludes a locking lever 70 for expanding and retracting expandablecollar 60. Locking sub-assembly 15 also comprises an internal finger 72(not shown) for extending through a window 47 formed in cannulasub-assembly 10.

It should be appreciated that although locking access cannula 5comprises two separate sub-assemblies, the two separate sub-assembliesmay be joined during manufacture so as to create a single construction.At the time of manufacture, locking sub-assembly 15 is mounted ontocannula sub-assembly 10 so that finger 72 is aligned with window 47 (inorder that the finger can thereafter be selectively moved through thewindow, as will hereinafter be discussed in further detail), and thenlocking sub-assembly 15 is secured onto cannula sub-assembly 10, e.g.,by ultrasonic welding.

In use, and looking next at FIGS. 20-24, a guidewire or access needle isfirst passed through the skin, through the intervening tissue, and theninto the hip joint. Next, locking access cannula 5, with obturator 50 inplace, is passed coaxially over the guidewire (not shown), through theintervening tissue 75, and into the interior of the capsule of the hip(FIG. 20). Then obturator 50 is removed from the cannula and theguidewire is removed from the cannula (FIG. 21). Locking lever 70 isthen actuated so as to enlarge expandable collar 60 on the distal end oflocking sub-assembly 15. This causes expandable collar 60 to enlargewith the enlarged collar 60 being located on the joint side of thecapsule. This helps hold the distal end of the cannula in place withinthe capsule (FIG. 22).

Thereafter, if desired, locking access cannula can then be positioned bythe surgeon so that expandable collar 60 is pressed against the interiorsurface of the capsule, and the capsule can then be “tented” by pullingoutwardly on the proximal end of the locking access cannula whereby tocreate additional workspace between the capsule and the hip joint.

Locking lever 70 may be “un-locked” so as to withdraw finger 72 fromwindow 47, so as to allow a scope or other instrument 80 to beintroduced through the lumen of cannula sub-assembly 10 and down to thesurgical site (FIG. 23). Locking lever 70 can then be actuated again soas to cause finger 72 to protrude through window 47 into the lumen ofcannula sub-assembly 10 and thereby lock the scope or other instrument80 to the inner cannula sub-assembly 10, and hence to locking accesscannula 5.

It should be appreciated that although locking lever 70 may actuate bothexpandable collar 60 and finger 72, more preferably, separate lockinglevers 70 can be used to separately actuate expandable collar 60 andfinger 72. Significantly, a surgeon can actuate a first lever to openexpandable collar 60 and lock the distal end of the cannula within thecapsule, and then be able to move the cannula so as to “tent” thetissue. In this embodiment of the present invention, a surgeon can theninsert and/or otherwise move a scope within the locking access cannulaand then actuate a second lever to lock the scope to the locking accesscannula.

It should also be appreciated that expandable collar 60 may be expandedby other mechanisms well known in the art (e.g., fluid or air expansion,etc.).

In view of the foregoing, locking access cannula 5 can be used as bothan access cannula for delivering scopes or other instruments to asurgical site, as well as used to create additional workspace in the hipjoint during a procedure.

Access Cannula with Expansion Wheel Tensioner

In another preferred embodiment, the present invention is directed to acannula that allows quick access to the interior of the hip joint whilealso providing an expansion wheel mechanism for creating additionalworkspace.

Looking next at FIGS. 25-27, there is shown a tensioning access cannula100 formed in accordance with the present invention. Tensioning accesscannula 100 generally comprises a hollow tube 105 having a distal end110 terminating in capsule locking sleeve 115, and a proximal end 120terminating in a proximal hub 125.

Tensioning access cannula 100 includes a central lumen opening on itsdistal end and may include a proximal seal for selectively sealing thecentral lumen and/or a proximal luer lock for introducing or removingfluid from the surgical site. Preferably tensioning access cannulaincludes a cannulated obturator (not shown) for selectively filling thelumen of hollow tube 105, e.g., when tensioning access cannula 100 isinserted into the body.

Hollow tube 105 is partially threaded along a portion T of its lengthand also comprises an expansion wheel tensioner 130 mounted thereon. Itshould be appreciated that expansion wheel tensioner 130 has acomplementary thread to threaded portion T of hollow tube 105, so as toallow expansion wheel tensioner 130 to move laterally along threadedportion T of hollow tube 105.

Proximal hub 125 comprises an actuator 135 for expanding capsule lockingsleeve 115.

In use, and looking next at FIGS. 26 and 27, a guidewire or accessneedle is first passed through the skin, through the intervening tissue,and then into the hip joint. Next, tensioning access cannula 100, withits obturator in place (not shown), is passed coaxially over theguidewire (not shown), through the intervening tissue 140, and to theinterior of the capsule of the hip (FIG. 26). Then the obturator isremoved from the cannula and the guidewire is removed from cannula.Actuator 135 is then actuated so as to expand capsule locking sleeve 115so as to form a collar shape. Expansion wheel tensioner 130 is thentightened by the surgeon so as to shorten the distance between expansionwheel 130 and the enlarged capsule locking sleeve 115. This causescapsule C to be “tented” by the retracting enlarged capsule lockingsleeve 115 (FIG. 27). Thus, tensioning access cannula 100 can be used toincrease the workspace inside the hip joint, in the peripheralcompartment.

By virtue of the fact that expansion wheel tensioner 130 is movablythreaded on threaded portion T of hollow tube 105, it can be used toadjust the tension applied to the tissue during the procedure. This isimportant since during a lengthy procedure, the tissue tends to swelldue to the retention of saline fluids applied to the surgical site.Thus, the provision of expansion wheel tensioner 130 allows a surgeon toadjust the tension applied to the tissue so as to accommodate for tissueswelling.

In addition, since the enlarged capsule locking sleeve 115 and expansionwheel tensioner 130 form a stable construct, the tissue can bemaintained in its tented position without constant manual intervention.This “hands-free” operation can be extremely useful to the surgeon.

In view of the foregoing, tensioning access cannula 100 can be used asboth an access cannula for delivering scopes or other instruments to asurgical site, as well as used to create additional workspace in the hipjoint and to adjust tension applied to tissue during a procedure.

Capsule Retraction with an Anchor Attached to a Length of Suture

In another embodiment of the present invention, and looking now at FIGS.28A-28E, an anchor 2000 attached to a length of suture S may be used toretract the capsule in order to create additional workspace in the hipjoint. Anchor 2000 comprises a body 2005 which is attached at a centerportion to a length of suture S. Body 2005 may be formed from a shapememory or super elastic material (e.g., nitinol) so that body 2005 mayassume a first, folded configuration (FIGS. 28A and 28B) when body 2005is in a stressed condition and a second, straight configuration (FIG.28E) when body 2005 is in a non-stressed condition.

In use, and looking now at FIGS. 28F-28I, anchor 2000, with suture Sattached, is folded in half and passed through a sheath 2010 whichmaintains body 2005 in its first, folded configuration. Sheath 2010 isthen passed through capsule C so that the distal end of sheath 2010 ispositioned within the interior of the joint (FIG. 28F). Using a push rod2015, body 2005 is pushed through the distal end of sheath 2010, forcingbody 2005 into its second, straight configuration (FIG. 28G). Sheath2010 and push rod 2015 can now be removed from the joint (FIG. 28H) andsuture S can be manipulated so as to position body 2005 against theinterior surface of the capsule. The capsule can then be “tented” bypulling suture S proximally, whereby to create additional workspacebetween the capsule and the hip joint (FIG. 28I).

Capsule Retraction with a Rod Having a Pivoting Distal End

In another embodiment of the invention, and looking now at FIG. 29 andFIGS. 29A-D, a rod 3000 may be used to retract capsule C in order tocreate additional workspace in the hip joint. Rod 3000 comprises anelongated shaft 3005 having a distal end 3010 with a pivot point 3020axially spaced from distal end 3010. Preferably, distal end 3010comprises a sharpened distal end so that rod 3000 may be passed directlythrough the capsule. However, if desired, rod 3000 (with or without asharpened distal tip) may also be passed through a cannula or sheathpositioned against the capsule. Rod 3000 also comprises a pull wire 3025(FIG. 29C) extending through the center of elongated shaft 3005 whichmay be pushed or pulled in order to pivot distal end 3010 (at pivotpoint 3020) from a first position in which distal end 3010 issubstantially aligned with the longitudinal axis of elongated shaft 3005(FIGS. 29A-C) to a second position in which distal end 3010 extends atan angle (e.g., perpendicularly) to the longitudinal axis of elongatedshaft 3005 (FIGS. 29 and 29D).

In use, and looking now at FIGS. 29E and 29F, pull wire 3025 (not shownin FIGS. 29E and 29F, but shown in FIGS. 29C and 29D) is pulledproximally so as to position distal end 3010 in its first position. Rod3000 is then inserted percutaneously directly through capsule C. Afterdistal end 3010 of elongated shaft 3005 passes through capsule C (FIG.29E), pull wire 3025 may be pushed distally in order to cause distal end3010 to pivot from its first position to its second position, withdistal end 3010 positioned against the interior surface of capsule C(FIG. 29F). Elongated shaft 3005 may then be pulled proximally so as to“tent” capsule C and create additional workspace between the capsule andthe head of the femur. After a surgeon no longer needs access to the hipjoint, pull wire 3025 may be pulled proximally in order to cause distalend 3010 to pivot back to its first position and rod 3000 may be removedfrom the joint.

Capsule Retraction with a Rod Having a Projection

Looking now at FIG. 30, a rod 4000 may be used to retract capsule C inorder to create additional workspace in the hip joint. Rod 4000comprises an elongated shaft 4005 having a distal end 4010 with a pivotpoint 4020 axially spaced from distal end 4010. A projection 4025 isattached to elongated shaft 4005 at pivot point 4020. Rod 4000 alsocomprises a length of wire having two portions 4030 and 4035 extendingalong the longitudinal axis of elongated shaft 4005 and configured tocause projection 4025 to move from a first position which issubstantially aligned with elongated rod 4005 to a second position inwhich projection 4025 extends at an angle to the longitudinal axis ofelongated shaft 4005.

In use, and looking now at FIGS. 30A and 30B, the wire is manipulated soas to position projection 4025 in its first position. Rod 4000 may thenbe passed directly through the capsule, or through a cannula or sheath4040 positioned through the capsule. After distal end 4010 of elongatedshaft 4005 passes through capsule C (FIG. 30A), portion 4035 of the wiremay be pulled proximally in order to cause projection 4025 to move fromits first position to its second position (FIG. 30B). Rod 4000 may nowbe manipulated so as to position projection 4025 against the neck of thefemur. When projection 4025 (extending at an angle to shaft 4005) ispositioned against the neck of the femur, the projection pushes againstthe neck of the femur, which causes capsule C to stretch and retractbetween the neck of the femur and the interior surface of the capsule,thereby creating additional workspace within the joint. After a surgeonno longer needs access to the hip joint, portion 4030 of the wire may bepulled proximally in order to cause projection 4025 to rotate back toits first position and rod 4000 may be removed from the joint.

Capsule Retraction with a Rod Having a Corkscrew

In another embodiment of the invention, and looking now at FIG. 31, arod 5000 having a corkscrew may be used to retract capsule C in order tocreate additional workspace in the hip joint. Rod 5000 comprises a body5005 having a corkscrew 5010 at its distal end.

In use, and looking now at FIGS. 31A-31C, rod 5000 may be passed througha cannula or needle 5015 positioned on the outside surface of capsule C,so that corkscrew 5010 of body 5005 is also positioned on the outsidesurface of capsule C (FIG. 31A). Body 5005 is then rotated so as tocause corkscrew 5010 to advance into capsule C, thereby engaging capsuleC (FIG. 31B). Rod 5000 may then be pulled proximally so as to “tent”capsule C away from the joint, whereby to create additional workspace inthe hip joint (FIG. 31C).

Capsule Retraction with Suture

In another embodiment of the invention, a device and method are providedwhich may be used when the capsule is cut open, e.g., in a manner shownin FIG. 33, in order to create additional workspace within the hipjoint.

Looking now at FIG. 32, a device for creating additional workspacewithin the joint is provided. The device shown in FIG. 32 comprises alength of suture S with a T-bar anchor 6000 a secured to one end of thelength of suture S and a T-bar anchor 6000 b secured to the other end ofthe length of suture S.

In an alternative form of the present invention, T-bar anchor 6000 b isomitted from the device. In this embodiment, the device comprises alength of suture S having a T-bar anchor 6000 a secured to one end ofthe length of suture S, with the other end of the length of sutureremaining free.

The device shown in FIG. 32, and the device omitting T-bar anchor 6000b, may be used in the following manner to create additional workspacewithin the hip joint.

Looking first at FIG. 33, a T-shaped cut (or any other shaped cut whichcreates two edges in the capsule) is made in capsule C in order tocreate two flaps, F1 and F2, and expose both the head of the femur andthe acetabular cup.

Looking now at FIGS. 34-38B, a push rod 6005 is used to load suture S,with at least one T-bar anchor extending therefrom, through a needle6010 (FIG. 34). Needle 6010 is passed percutaneously through the skin,into the hip joint and through flap F1 of capsule C. A second needle6010, with a suture S and at least one T-bar anchor loaded within theneedle, is passed percutaneously through the skin, into the hip jointand through flap F2 of capsule C (FIG. 35). Push rod 6005 is used topush T-bar anchor 6000 a and suture S through needle 6010 so that T-baranchor 6000 a extends out of the distal end of needle 6010 and into theinterior of the capsule, leaving T-bar anchor 6000 a located within theinterior of the capsule and a length of suture extending to the exteriorof the capsule (FIGS. 36A and 36B).

Looking next at FIG. 37, both push rod 6005 and needle 6010 are removedfrom capsule C, and suture S is pulled proximally so as to lock T-baranchor 6000 a on the underside of capsule C.

The two ends of suture S extending from T-bar anchors 6000 a may now bepulled proximally so as to retract flaps F1 and F2 of capsule C (FIGS.38A and 38B). This permits a surgeon improved access to the neck of thefemur normally covered by the capsule.

It is important to note that the T-shaped cut in the capsule can also bemade in the capsule after T-bar anchors 6000 a have been locked on theunderside of capsule C rather than before the T-bar anchors are lockedon the underside of the capsule, as described above. Additionally, T-baranchors 6000 a could be used in capsule C where no cut is made; in otherwords, T-bar anchors 6000 a are placed in a region of the capsule whereit is desired to tent, or retract, the capsule.

Once the necessary arthroscopic procedures are completed. T-bar anchors6000 a may be removed from the joint as follows.

Looking now at FIG. 39, a cannula 6015 may be inserted into the capsuleand grasping forceps 6020 may be passed through the cannula to graspeach T-bar anchor 6000 a from the underside of capsule C (FIG. 39). EachT-bar anchor 6000 a, with suture S attached, is then pulled proximallyfrom the underside of capsule C until all the suture is removed from thejoint space through the cannula. It is important to note that, whenT-bar anchor 6000 b is attached to the other end of the length ofsuture, T-bar anchor 6000 b may be cut from the end of the suture priorto pulling T-bar anchor 6000 a from the underside of capsule C so thatthe other end of the length of suture is free to slide out of the joint(in this example, from the skin to the capsule through the adjoiningtissue structures).

Instead of removing T-bar anchors 6000 a from the joint, it may also bedesirable to close capsule C using T-bar anchors 6000 a, with T-baranchors 6000 a remaining in the joint after the capsule has been closed.In this embodiment, and looking now at FIGS. 40-43, a cannula 6015 maybe inserted into the capsule and a grasping or hooking instrument 6020may be passed through the cannula to grasp or hook the portion of thesuture positioned on the outside of capsule C (FIG. 40). Each leg of thesuture is passed up through the cannula (FIG. 41) until two free ends ofsuture extend from the capsule (FIG. 42). The two free ends of thesuture extending from the capsule may then be tied off (e.g., using ahalf hitch or other non-sliding knot well known to those skilled in theart) so as to re-stitch and secure the capsule (FIG. 43). If desired,suture S and T-bar anchors 6000 a may be formed from an absorbablematerial so that they dissolve over time.

In another embodiment, it may be desirable to remove T-bar anchors 6000a from the joint, and close the capsule, leaving only suture S in thejoint. In this embodiment, and looking now at FIG. 44, a cannula 6015may be inserted into the capsule and a grasping or hooking instrument6020 may be passed through the cannula to grasp or hook the portion ofthe suture positioned on the outside of capsule C. Each leg of thesuture is passed up through the cannula until two free ends of sutureextend from the capsule. Once the free ends of suture S have been passedup through the cannula, a knot 6025 is formed on the free ends of sutureS. Subsequently, a grasping instrument may be used to grasp each T-baranchor 6000 a from the underside of capsule C (not shown). Each T-baranchor 6000 a, with suture S attached, is then pulled proximally fromthe underside of capsule C until T-bar anchors 6000 a are removed fromthe joint space through the cannula. As the T-bar anchors are removedfrom the joint space, knot 6025 is positioned along the capsule. Theends of the suture with T-bar anchors 6000 a may then be tied off (e.g.,using a half hitch or other non-sliding knot well known to those skilledin the art) so as to re-stitch and secure the capsule (not shown). Ifdesired, suture S may be formed from an absorbable material so that thesutures dissolve over time.

In still another embodiment of the present invention, it may bedesirable to close capsule C using T-bar anchors 6000 a and 6000 b, withT-bar anchors 6000 b remaining in the joint after the capsule has beenclosed. In this embodiment, and looking now at FIGS. 45-48, a cannulamay be inserted into the capsule and grasping forceps may be passedthrough the cannula to grasp each T-bar anchor 6000 a from the undersideof capsule C (FIG. 45). Each T-bar anchor 6000 a, with suture Sattached, is then pulled proximally from the underside of capsule C(FIG. 46) until T-bar anchors 6000 b are resting on the outside ofcapsule C (FIG. 47A-47C). The free ends of the suture extending from thecapsule may then be tied off (e.g., using a half hitch or othernon-sliding knot well known to those skilled in the art) so as tore-stitch and secure the capsule (FIG. 48). If desired, suture S may beformed from an absorbable material so that the sutures dissolve overtime

In another form of the present invention, and looking at FIG. 49, alength of suture may be used to retract capsule C, and a cannula 7000having a projection 7005 may be used to secure the suture so as tomaintain the capsule in the retracted position while the necessaryarthroscopic procedures are completed.

In use, a T-shaped cut (or any other shaped cut which creates two edgesin the capsule) is made in capsule C so as to create two flaps, F1 andF2, and expose both the head of the femur and the acetabular cup.

A push rod may be used to load suture S through a needle (not shown).The needle is passed through cannula 7000 and through flap F1 of capsuleC so that two free ends of suture S extend from flap F1. A secondneedle, with suture S loaded therein, is passed through cannula 7000 band through flap F2 of capsule C so that two free ends of suture Sextend from flap F2. Each of the two free ends of suture S may now bepulled proximally so as to retract flaps F1 and F2 of capsule C. Inorder to permit a surgeon to better access the hip joint, each of thetwo free ends of suture extending from the flaps can be tied aroundprojection 7005 in order to maintain the flaps in their retractedposition.

Projection 7005 may comprise a post on which to wrap suture S. Post mayinclude a narrow slit to capture a portion of suture S. The slit isnarrower than the width of suture S so that the slit squeezes the sutureto provide a gripping force. The slit may be formed out of anelastomeric material. Alternatively, projection 7005 may comprise aclamp into which suture S is secured. Clamp may be activated manually orwith a spring.

It is important to note that a length of suture may also be used toretract capsule C, and cannula 7000 with projection 7005 may be used tosecure the suture so as to maintain the capsule in the retractedposition even when a cut has not been made in the capsule.

Capsule Retraction with a Rod Having a Hook

Looking now at FIG. 50, a rod 8000 having a hook 8005 may be used toretract capsule C after the capsule has been cut open, e.g., in a mannershown in FIG. 33 (or any other shaped cut which creates two edges in thecapsule), in order to create additional workspace in the hip joint. Rod8000 comprises a body 8005 having a hook 8010 at its distal end.

In use, a T-shaped cut is made in capsule C so as to create two flaps,and expose both the neck and/or head of the femur and/or the acetabularcup. Hook 8010 of rod 8000 may be positioned underneath a flap of thecut capsule. Rod 8000 may then be pulled proximally so as to piercecapsule C and retract capsule C away from the joint.

Use of the Present Method and Apparatus for Other Joints, Etc.

It should be appreciated that the present systems and methods disclosedherein may also be used for increasing the workspace in joints inaddition to the hip joint, e.g., the present methods and systems may beused to increase the workspace in the knee joint, the shoulder joint,etc. Furthermore, the present methods and systems may also be used toincrease workspace in other interior bodily spaces, e.g., the abdomen,the bladder, regions around the spine, etc.

Modifications of the Preferred Embodiments

It should be understood that many additional changes in the details,materials, steps and arrangements of parts, which have been hereindescribed and illustrated in order to explain the nature of the presentinvention, may be made by those skilled in the art while still remainingwithin the principles and scope of the invention.

1.-122. (canceled)
 123. A method of closing a capsule of a joint, themethod comprising: forming a cut in the capsule of the joint so as tocreate a first flap of the capsule and a second flap of the capsule;providing a first length of suture having a first anchor attached to oneend of the first length of suture; providing a second length of suturehaving a second anchor attached to one end of the second length ofsuture; passing the first length of suture through the first flap of thecapsule of the joint so that the first anchor is positioned against anexterior surface of the first flap of the capsule of the joint and thefirst length of suture extends out of the joint; passing the secondlength of suture through the second flap of the capsule of the joint sothat the second anchor is positioned against an exterior surface of thesecond flap of the capsule of the joint and the second length of sutureextends out of the joint; tying the first length of suture and thesecond length of suture together so as to close the capsule of thejoint.
 124. The method according to claim 123 wherein the method furthercomprises: prior to tying the first length of suture and the secondlength of suture together, pulling at least one of the first and secondlengths of suture so as to retract at least one of the first and secondflaps of the capsule of the joint; and performing an arthroscopicprocedure in the joint while the capsule is retracted.
 125. The methodaccording to claim 123 wherein at least one of the first and secondanchors comprises a T-bar anchor.
 126. The method according to claim 123wherein at least one of the first and second anchors comprises a bodywhich is configured to assume (i) a first, folded configuration when thebody is in a stressed condition, and (ii) a second, straightconfiguration when the body is in an unstressed condition.
 127. Themethod according to claim 123 wherein passing the first length of suturethrough the first flap of the capsule of the joint comprises loading thefirst length of suture through a needle and passing the needle throughthe first flap of the capsule.
 128. The method according to claim 123wherein passing the second length of suture through the second flap ofthe capsule of the joint comprises loading the second length of suturethrough a needle and passing the needle through the second flap of thecapsule.
 129. The method according to claim 123 wherein the first anchoris positioned against the exterior surface of the first flap of thecapsule by passing the first length of suture through the first flap ofthe capsule and pulling the first length of suture until the firstanchor is positioned against the exterior surface of the first flap ofthe capsule.
 130. The method according to claim 123 wherein the secondanchor is positioned against the exterior surface of the second flap ofthe capsule by passing the second length of suture through the secondflap of the capsule and pulling the second length of suture until thesecond anchor is positioned against the exterior surface of the secondflap of the capsule.
 131. The method according to claim 123 wherein thecut is formed in the capsule of the joint before positioning the firstanchor and the second anchor against the exterior surface of the firstflap and the exterior surface of the second flap, respectively.
 132. Themethod according to claim 123 wherein the cut is formed in the capsuleof the joint after positioning the first anchor and the second anchoragainst the exterior surface of the first flap and the exterior surfaceof the second flap, respectively.
 133. A method of retracting a capsuleof a joint, the method comprising: forming a cut in the capsule of thejoint so as to create a first flap of the capsule and a second flap ofthe capsule; providing a first length of suture having a first anchorattached to one end of the first length of suture; providing a secondlength of suture having a second anchor attached to one end of thesecond length of suture; passing the first length of suture through thefirst flap of the capsule of the joint so that the first anchor ispositioned against a surface of the first flap of the capsule of thejoint and the first length of suture extends out of the joint; passingthe second length of suture through the second flap of the capsule ofthe joint so that the second anchor is positioned against a surface ofthe second flap of the capsule of the joint and the second length ofsuture extends out of the joint; pulling at least one of the first andsecond lengths of suture so as to retract at least one of the first andsecond flaps of the capsule of the joint; and performing an arthroscopicprocedure in the joint while the capsule is retracted.
 134. The methodof claim 133 wherein the method further comprises tying the first lengthof suture and the second length of suture together so as to close thecapsule of the joint.
 135. The method according to claim 133 wherein thefirst and second anchors are positioned against the exterior surface ofthe first and second flaps, respectively, of the capsule of the joint.136. The method according to claim 133 wherein the first and secondanchors are positioned against the interior surface of the first andsecond flaps, respectively, of the capsule of the joint.
 137. The methodaccording to claim 133 wherein at least one of the first and secondanchors comprises a T-bar anchor.
 138. The method according to claim 133wherein at least one of the first and second anchors comprises a bodywhich is configured to assume (i) a first, folded configuration when thebody is in a stressed condition, and (ii) a second, straightconfiguration when the body is in an unstressed condition.
 139. Themethod according to claim 133 wherein passing the first length of suturethrough the first flap of the capsule of the joint comprises loading thefirst length of suture through a needle and passing the needle throughthe first flap of the capsule.
 140. The method according to claim 133wherein passing the second length of suture through the second flap ofthe capsule of the joint comprises loading the second length of suturethrough a needle and passing the needle through the second flap of thecapsule.
 141. The method according to claim 135 wherein the first anchoris positioned against the exterior surface of the first flap of thecapsule by passing the first length of suture through the first flap ofthe capsule and pulling the first length of suture until the firstanchor is positioned against the exterior surface of the first flap ofthe capsule.
 142. The method according to claim 135 wherein the secondanchor is positioned against the exterior surface of the second flap ofthe capsule by passing the second length of suture through the secondflap of the capsule and pulling the second length of suture until thesecond anchor is positioned against the exterior surface of the secondflap of the capsule.
 143. The method according to claim 136 wherein thefirst anchor is positioned against the interior surface of the firstflap of the capsule by passing the first length of suture and the firstanchor through the first flap of the capsule and pulling the firstlength of suture until the first anchor is positioned against theinterior surface of the first flap of the capsule.
 144. The methodaccording to claim 136 wherein the second anchor is positioned againstthe interior surface of the second flap of the capsule by passing thesecond length of suture and the second anchor through the second flap ofthe capsule and pulling the second length of suture until the secondanchor is positioned against the interior surface of the second flap ofthe capsule.
 145. The method according to claim 133 wherein the cut isformed in the capsule of the joint before positioning the first anchorand the second anchor against the surface of the first flap and thesurface of the second flap, respectively.
 146. The method according toclaim 133 wherein the cut is formed in the capsule of the joint afterpositioning the first anchor and the second anchor against the surfaceof the first flap and the surface of the second flap, respectively. 147.A method for manipulating a capsule of a joint, the method comprising:forming a cut in the capsule of the joint so as to create a first flapof the capsule and a second flap of the capsule; providing a firstlength of suture having a first anchor attached to one end of the firstlength of suture; providing a second length of suture having a secondanchor attached to one end of the second length of suture; passing thefirst length of suture through the first flap of the capsule of thejoint so that the first anchor is positioned against an exterior surfaceof the first flap of the capsule of the joint and the first length ofsuture extends out of the joint; passing the second length of suturethrough the second flap of the capsule of the joint so that the secondanchor is positioned against an interior surface of the second flap ofthe capsule of the joint and the second length of suture extends out ofthe joint; tying the first length of suture and the second length ofsuture together so as to close the capsule of the joint.
 148. The methodaccording to claim 147 wherein the method further comprises: prior totying the first length of suture and the second length of suturetogether, pulling at least one of the first and second lengths of sutureso as to retract at least one of the first and second flaps of thecapsule of the joint; and performing an arthroscopic procedure in thejoint while the capsule is retracted.
 149. The method according to claim147 wherein at least one of the first and second anchors comprises aT-bar anchor.